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What is the registration timeline for Class III medical devices in the United States?
Category：行業(yè)資訊 Date：2024-09-04 17:25:14 Author: Source:
On average, the entire process can take anywhere from 1 to 2 years, though it may be longer for more complex devices or if the FDA requires additional data.

The registration timeline for Class III medical devices in the United States varies depending on several factors, including the complexity of the device, the completeness of the submission, and the FDA's review workload. Generally, the process can take between several months to over a year.7.jpg

Here’s a rough breakdown of the timeline:

  1. Pre-Submission Meetings (Optional but Recommended):
    These meetings with the FDA can take a few months to schedule and conduct.

  2. Preparation of the Premarket Approval (PMA) Application:
    Preparing the PMA, including all necessary testing and documentation, can take several months to years depending on the device's complexity.

  3. FDA Review Process:

    • Filing Review: The FDA has 45 days to review the PMA submission for completeness.
    • Substantive Review: Once the PMA is filed, the FDA typically completes its substantive review within 180 days, but this period can be extended if additional information is required.
    • Panel Review (if applicable): For high-risk devices, a review by an advisory panel may be necessary, adding a few more months to the timeline.
    • Final Decision: After the review, the FDA will either approve or deny the PMA. This final decision can take several months.

  4. Total Time:
    On average, the entire process can take anywhere from 1 to 2 years, though it may be longer for more complex devices or if the FDA requires additional data.

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